Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

This study has been completed.

Sponsor:

Sanofi

ClinicalTrials.gov Identifier:

NCT00631579

First Posted: March 7, 2008

Last Update Posted: October 2, 2009

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Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

Official Title ICMJE

Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.

Brief Summary

The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.

Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.